South Africa

HIV/AIDS Statistics for South Africa

Total population in thousands (2007): 48,577*
Number of people living with HIV (2007): 5,700,000*
Adults aged 15 and up living with HIV (2007): 5,400,000*
Women aged 15 and up living with HIV (2007): 3,200,000*
Women aged 15 to 24 prevalence rate (2007): 12.7*
Men aged 15 to 24 prevalence rate (2007): 4.0*
Deaths due to AIDS (2007): 350,000*
Estimated antiretroviral therapy coverage (Dec 2007): 28%
Estimated number of pregnant women living with HIV (2007): 220,000


Ongoing biomedical HIV prevention research trials in South Africa

Vaccines

Trial: IAVI B003/IPCAVD-004
Phase: I
Start Date: October 2010
Sponsor, funder, developer: IAVI, HVTN,NIAID, Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT, Harvard
Total participants: 212
Vaccine(s): Prime: Ad26.EnvA01 Boost: Ad35- ENV

Trial: HVTN 204
Phase: II
Start Date: August 2006
Sponsor, funder, developer: NIAID, HVTN
Total participants: 480
Vaccine(s): DNA vaccine: VRC-HIVDNA016-00-VP, followed by adenoviral vector vaccine, VRC-HIVADV014-00-VP
Clade: A, B, C

Trial: Safety of and immune response to HIV vaccines SAAVI DNA-C2 and SAAVI MVA-C [HVTN 073]
Phase: I
Product Being Tested: A prime boost strategy with SAAVI DNA-C2 and SAAVI MVA-C; DNA plasmid vaccine with gag, RT, tat, nef, env
Sponsor, funder, developer, collaborator:HIV Vaccine Trials Network, South African AIDS Vaccine Initiative, Crossroads, Chris Hani Baragwanath Hospital
Total participants: 48
Countries: South Africa, US
Trial sites in South Africa: Soweto
Results expected: n/a
For more information: http://www.iavireport.org/trials-db/Pages/ShowTrial.aspx?TrialID=1464
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Microbicides

Trial: Safety and acceptability of dapivirine gel, conducted using daily monitored adherence in healthy HIV-negative women [IPM 014A]
Phase: I/II
Product Being Tested: Dapivirine gel
Sponsor, funder, developer, collaborator:International Partnership for Microbicides
Total participants: 320
Countries: Kenya, Malawi, Rwanda, South Africa
Trial sites in South Africa: Brits, North West Province; Cape Town, Western Cape; Ladysmith, KwaZulu Natal; Paarl, Eastern Cape; Pinetown, KwaZulu Natal
Results expected: n/a
For more information: http://clinicaltrials.gov/ct2/show/NCT00917904?term=IPM014B&rank=1


Trial: Dapivirine vaginal gel safety [IPM 014B]
Phase: I/II
Product Being Tested: Dapivirine vaginal gel
Sponsor, funder, developer, collaborator: International Partnership for Microbicides
Total participants: 320
Countries: South Africa
Trial sites in US: n/a
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00917904?term=dapivirine+gel&rank=3


Trial: Dapivirine vaginal ring safety [IPM 015]
Phase: I/II
Product Being Tested: Dapivirine vaginal ring
Sponsor, funder, developer, collaborator: International Partnership for Microbicides
Total participants: 280
Countries: South Africa, Kenya, Malawi, Rwanda, Tanzania
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT01071174?term=dapivirine+vaginal+ring&rank=1


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Pre-Exposure Prophylaxis

Trial: Pre-Exposure Prophylaxis Initiative [iPrEx]
Phase: III
Product Being Tested: Daily oral TDF/FTC (Truvada®)
Sponsor, funder, developer, collaborator: National Institute of Health, Bill and Melinda Gates Foundation, Fenway Community Health, San Francisco Department of Public Health
Total participants: 2,499
Countries: Brazil, Ecuador, Peru, South Africa, Thailand, US
Trial sites in US: Boston, MA
Results expected: Announced in Q4 2010. For more information visit theGlobal iPrEx page or AVAC's iPrEx page
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PrEP & Microbicides

Trial: Vaginal and Oral Interventions to Control the Epidemic [VOICE (MTN 003)]
Phase: IIb
Product Being Tested: Daily oral TDF; daily oral TDF/FTC; daily topical tenofovir gel
Sponsor, funder, developer, collaborator:Microbicide Trials Network, National Institutes of Health
Total participants: 5,000
Countries: Malawi, South Africa, Uganda, Zimbabwe
Trial sites in South Africa: Durban, KwaZulu Natal; Klerksdorp, Johannesburg
Results expected:2013
For more information: http://www.mtnstopshiv.org/news/studies/mtn003


Trial: Adherence and pharmacokinetics study of oral and vaginal preparations of tenofovir [MTN-001]
Phase: IIb
Product Being Tested: Tenofovir gel, oral TDF
Sponsor, funder, developer, collaborator:Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institue of Mental Health ; Gilead, CONRAD
Total participants: 144
Countries: South Africa, Uganda, US
Trial sites in South Africa: Durban, KwaZulu Natal
Results expected: 2010
For more information: , http://clinicaltrials.gov/ct2/show/NCT00592124?term=MTN-001&rank=1 http://www.mtnstopshiv.org/news/studies/mtn001
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Partner Treatment

Trial: Evaluation of the effectiveness of two antiretroviral treatment strategies to prevent HIV transmission in HIV-serodiscordant couples [HPTN 052]
Phase: III
Product Being Tested: Highly active antiretroviral therapy for HIV prevention
Sponsor, funder, developer, collaborator:HIV Prevention Trials Network, Soweto HPTN, Witwatersrand Clinical Research Site, Helen Joseph Hospital
Total participants: 1,750 couples
Countries: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, Zimbabwe
Trial sites in South Africa: Johannesburg
Results expected: n/a
For more information: http://www.hptn.org/research_studies/hptn052.asp
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*WHO, UNAIDS, and UNICEF. Epidemiological Fact Sheet on HIV and AIDS: Core data on epidemiological and response South Africa 2008 Update. 2008. http://apps.who.int/globalatlas/predefinedReports/EFS2008/full/EFS2008_ZA.pdf
†WHO, UNAIDS, and UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector: Progress Report. 2008.
http://www.who.int/hiv/pub/towards_universal_access_report_2008.pdf